| The introduction of spinal fusion devices has made a huge advance in the treatment of lower back pain. Currently, a range of devices exists manufactured from either Ti alloy or reinforced PEEK. A four year European Community funded project has researched the benefits of using ceramic materials in spinal surgery. This has resulted in a ceramic composite spinal fusion device with the benefits of: • Faster bone fusion • No allograft or autologous bone graft • Anterior and posterior operative procedures • Optimum biomechanical stability In Vitro Data In vitro testing was conducted to characterise the spinal fusion implant according to mechanical, biochemical and biocompatible criteria. These include • Osteoblast cell proliferation testing • Direct contact cell culture toxicity tests (ISO 10993-5) • Agar diffusion cell culture screening for cytotoxicity (ASTM F895) • Modified agar diffusion cytotoxicity (ASTM F895) • In vitro degradation tests Results confirmed the device design for clinical testing and that all materials used are biocompatible and therefore suitable for the application. Clinical Data In vivo studies were performed to examine product performance Analyses include: • Osteoconduction and vascularisation of the tissue surrounding a prosthesis • Biomechanical push out tests • Tissue response testing • Biomechanical and histological examination In vivo assessment of the clinical model have indicated very positive results from 9 to 12 weeks post implantation as documented by X-ray, DEXA scanning, CT scanning techniques. Fusion is achieved with new bone completely surrounding the implant. 
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